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This is a single-center, pilot study being conducted to evaluate the safety and performance of the investigational device (MUST) in detecting malignant lesions in breast tissue.
This is a single-center, prospective, pilot study in which all enrolled subjects will receive the same screening mammography procedures (i.e., 3D mammography plus MUST).
Subjects will have between 1 and 4 clinic visits. The number of visits will be based upon the mammography and MUST findings, and whether additional procedures, such as MRI, biopsy, or a repeat MUST are warranted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | All enrolled subjects will undergo breast cancer screening with mammography and the MUST device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MUST device | Device | Imaging with MUST device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with true positive (malignant) breast lesions confirmed by biopsy | Sensitivity of MUST plus mammography versus mammography alone | 14 days |
| Number of subjects with false positive (benign) breast lesions confirmed by biopsy | Specificity of MUST plus mammography versus mammography alone | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of true positive and false positive breast lesions categorized by BI-RADS breast density category as determined by the screening mammogram | Assess the sensitivity and specificity by BI-RADS breast density category as determined by the Visit 1 mammogram, for MUST plus mammography vs mammography alone | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tejas Mehta, MD | Contact | 617-667-2506 | tmehta@bidmc.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Tejas Mehta, MD | Beth Israel Deaconess Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center BreastCare Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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All enrolled subjects will receive breast cancer screening with mammography and MUST
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| For subjects who undergo biopsy, comparison of MUST results with biopsy results |
In the subpopulation of subjects who undergo biopsy, the concordance of MUST with biopsy will be estimated |
| 60 days |
| For subjects test positive on mammography (initial BI-RADS score of 0 followed by an additional imaging BI-RADS score of 4 or 5) who undergo biopsy, comparison of MUST and MRI results with biopsy results | In the subpopulation of subjects who test positive on mammography (BI-RADS score of 4 or 5) and have a biopsy, sensitivity and specificity will be assessed and compared between MUST and MRI and biopsy results | 60 days |
| Number of subjects with true positive and false positive breast lesions at the 6 month follow up (if applicable) and the 12 month follow up phone call. | The co-primary endpoint of overall sensitivity and specificity will be reassessed after subjects have had the opportunity to complete the Month 6 MUST re-evaluation visit, if applicable, and again when all subjects have had the opportunity to complete the Month 12 follow-up phone call to identify events of interval cancer for MUST plus mammography as well as MUST alone | 12 months |
| Listing of adverse events experienced by subjects | Evaluate the safety of the MUST device by evaluating the adverse event profile | 6 months |